Guan Zhong-Zhen, Zhang Li, Li Long-Yun, Jiang Guo-Liang, Liu Xu-Yi, Chu Da-Tong, Zhao Hong-Yun, Li Wei
Skate Key Laboratory of Oncology in Southern China, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.
Ai Zheng. 2005 Aug;24(8):980-4.
BACKGROUND & OBJECTIVE: Gefitinib, a selective inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, has been approved to be used in treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in many countries. This study, a multicenter clinical trial, was designed to evaluate the efficacy of gefitinib on Chinese patients with locally advanced or metastatic NSCLC after failure of previous chemotherapy, and explore its safety.
A total of 159 pathologically-confirmed NSCLC patients were enrolled. Gefitinib was orally administered 250 mg once daily until disease progression or the occurrence of intolerable toxicity.
The objective response rate was 27.0%; the disease control rate was 54.1%. The median progression-free survival time was 97 days; the median overall survival time was 10.0 months; the 1-year survival rate was 44%. The most common drug-related adverse events were rash (44.0%), pruritus (15.7%), and diarrhea (10.1%), and most of them were grade 1-2 events with no need of further treatment.
Gefitinib is effective and safe in treating Chinese patients with locally advanced or metastatic NSCLC after failure of previous chemotherapy.
吉非替尼是一种表皮生长因子受体（EGFR）酪氨酸激酶的选择性抑制剂，已在许多国家被批准用于治疗局部晚期或转移性非小细胞肺癌（NSCLC）。本研究为一项多中心临床试验，旨在评估吉非替尼对既往化疗失败的中国局部晚期或转移性NSCLC患者的疗效，并探讨其安全性。
共纳入159例经病理确诊的NSCLC患者。吉非替尼口服给药，每日一次，每次250 mg，直至疾病进展或出现不可耐受的毒性。
客观缓解率为27.0%；疾病控制率为54.1%。中位无进展生存期为97天；中位总生存期为10.0个月；1年生存率为44%。最常见的药物相关不良事件为皮疹（44.0%）、瘙痒（15.7%）和腹泻（10.1%），且大多数为1-2级事件，无需进一步治疗。
吉非替尼对既往化疗失败的中国局部晚期或转移性NSCLC患者有效且安全。
